FDA.reportPublic FDA data

MECLIZINE

Manufacturer
Ulai Health LLC
Effective date
2025-01-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:21

Label at a glance#

ProductMECLIZINE
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Dosage and administration

dosage should be taken one hour before travel starts adults and children 12 years and over take 2 or 4 caplets once daily or as directed by a doctor 

Storage and handling

each caplet contains: calcium 28 mg store at 20 o -25°C (68 o -77°F)

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age unless directed by a doctor.

Do not take this product, unless directed by a doctor, if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use causion when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • dosage should be taken one hour before travel starts
adults and children 12 years and overtake 2 or 4 caplets once daily or as directed by a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: calcium 28 mg
  • store at 20 o-25°C (68 o-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-386-11

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

Ulai Meclizine 12.5 mg Caplet 1000 ct. LabelUlai Meclizine 12.5 mg Caplet 1000 ct. Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN3
995624meclizine hydrochloride 12.5 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MECLIZINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73057-386-082022-01-31C16284748780-1d6a99b39-84d4-a426-e053-dadaa90af4c2Drug Facts
73057-386-112022-01-31C16284748780-1d6a99b39-84d4-a426-e053-dadaa90af4c2Drug Facts
73057-386-082022-01-28C16284748780-1d6a99b39-84d4-a426-e053-dadaa90af4c2Drug Facts
73057-386-112022-01-28C16284748780-1d6a99b39-84d4-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73057-386-08MECLIZINE100 in 1 BOTTLE, PLASTICTABLET1003
73057-386-11MECLIZINE1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73057-386MECLIZINE (MECLIZINE HCL 12.5MG) TABLET [ULAI HEALTH LLC]3Current NDC, Legacy NDC, 2 package rows20250122_d304e205-85fa-494a-9a68-ae6855b139b1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73057-38673057-386-11, 73057-386-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINEMECLIZINE HCL 12.5MGUlai Health LLCd304e205-85fa-494a-9a68-ae6855b139b12025-01-20WarningsExact identifier
ndc (package): 73057-386-08
ndc (package): 73057-386-11
ndc (product): 73057-386
ndc11 (package): 73057038611
ndc11 (package): 73057038608
spl id: 2c27a466-defa-b729-e063-6394a90a61d3
spl set id: d304e205-85fa-494a-9a68-ae6855b139b1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.